Anti Allergic Medicine

RIBASURE (Ribavirin 200mg Capsules)

COMPOSITION:
Each Hard Gelatin Capsule Contains:

Ribavirin USP ………. 200 mg

PHARMACOLOGICAL CLASSIFICATION:

Antivirals for systemic use, nucleosides and nucleotides excl. reverse transcriptase inhibitors, ATC code: J05AB04.

PHARMACOLOGICAL ACTION:

Mechanism of action:

Ribavirin (RIBASURE) is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses. The mechanism by which RIBASURE in combination with other medicinal products exerts its effects against HCV is unknown.

Pharmacodynamics:
Antiviral Activity in Cell Culture

The antiviral activity of Ribavirin in the HCV-replicon is not well understood and has not been defined because of the cellular toxicity of Ribavirin.

Resistance HCV genotypes show wide variability in their response to pegylated recombinant human interferon/ribavirin therapy. Genetic changes associated with the variable response have not been identified.

Cross-resistance

There is no reported cross-resistance between pegylated/non-pegylated interferons and Ribavirin.

Pharmacokinetics:
Absorption

Ribavirin is absorbed rapidly following oral administration of a single dose (mean Tmax= 1.5 hours), followed by rapid distribution and prolonged elimination phases (single dose half-lives of absorption, distribution and elimination are 0.05, 3.73 and 79 hours, respectively). Absorption is extensive with approximately 10 % of a radiolabelled dose excreted in the faeces. However, absolute bioavailability is approximately 45 %-65 %, which appears to be due to first pass metabolism.

Distribution

Ribavirin transport in non-plasma compartments has been most extensively studied in red cells, and has been identified to be primarily via an es-type equilibrative nucleoside transporter.

Biotransformation

Ribavirin has two pathways of metabolism: 1) a reversible phosphorylation pathway; 2) a degradative pathway involving deribosylation and amide hydrolysis to yield a triazole carboxyacid metabolite. Both ribavirin and its triazole carboxamide and triazole carboxylic acid metabolites are also excreted renally.

Elimination

Upon multiple dosing, ribavirin accumulates extensively in plasma with a six-fold ratio of multiple-dose to single-dose AUC12hr.

Special populations:

Renal Dysfunction

The pharmacokinetics of ribavirin were assessed after administration of a single oral dose (400 mg) of ribavirin to non HCV-infected subjects with varying degrees of renal dysfunction.

The multiple-dose pharmacokinetics of ribavirin cannot be accurately predicted in patients with renal dysfunction. Ribavirin is not effectively removed by hemodialysis.

Hepatic Dysfunction

The effect of hepatic dysfunction was assessed after a single oral dose of ribavirin (600 mg).

Elderly Patients

Pharmacokinetic evaluations in elderly subjects have not been performed.

Gender

There were no clinically significant pharmacokinetic differences noted in a single-dose trial of 18 male and 18 female subjects.

Pediatric Patients

The pharmacokinetics of RIBASURE (dose-normalized) is similar in adults and pediatric subjects.

• Delivery Time: 7 to 14 Days

Abamune-L is taken with other antiretroviral medications to treat adults infected with HIV-1. A single pill is the equivalent of 300mg of lamivudine IP and 600mg of abacavir. At least one other anti-HIV medication must be co-administered with Abamune-L to effectively prevent HIV from progressing to AIDS.

The recommended dose of Abamune-L for adults is one pill daily along with other antiretroviral medications. Abamune-L may be taken with or without food.

Any patient who has hepatic impairment should not take Abamune-L. Anyone with a prior history of hypersensitive reaction to abacavir or any of the other ingredients in Abamune-L should also not take the drug. Do not take any abacavir containing products after experiencing a hypersensitive reaction.

Taking Abamune-L has been associated with the following side effects:

• migraine
• rash
• nausea
• fatigue
• vomiting
• diarrhea
• gastritis
• abnormal dreams
• vertigo
• headache
• fever
• anxiety
• depression
• insomnia

In rare incidences, cases of fatal hypersensitive reactions to abacavir, a core ingredient of Abamune-L, have been reported. Other side effects may occur. Let a doctor know immediately if you feel any changes in your well being when you begin taking Abamune-L.